Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

Kodak Flips The Script To Biopharma Manufacturing In Rochester

Well, that didn’t work out as planned, writes Chief Editor Louis Garguilo, referring to Kodak's plan in 2018 to revitalize the Eastman Business Park in Rochester, NY. The incoming chairman and now CEO, Jim Continenza, didn’t like that movie, and flipped the script. Instead, Kodak has, so to speak, returned to itself – back to a domestic specialty materials and chemicals supplier, intent on serving biopharma in that capacity.

GUEST COLUMNISTS

Minimizing Regulatory Risk For Biologics Manufacturing Changes
Any manufacturing process change for a biologic can raise comparability questions. Here’s a practical, action-oriented strategy to ensure health authorities are satisfied.
Building Quality Into Radiopharmaceuticals: A Look At EMA's Recent Guideline
The EMA's December 2025 draft guideline on expectations for the quality documentation of radiopharmaceuticals replaces the earlier 2007 guideline and reflects significant developments.
Overcoming 3 Key Challenges Of Working With CDMOs For Radiopharmaceuticals
Radiopharmaceuticals have a level of operational complexity that challenges traditional outsourcing models. Address these three critical challenges early and intentionally.
Selecting The Right eQMS To Maximize Quality Maturity
Let's take a closer look at the current electronic quality management system (eQMS) landscape in pharma/biotech and what a future-ready eQMS must enable to support continuous improvement.
How AI Could Clear Logistics Roadblocks Limiting Patient Access To CGT
Patient access often gets mischaracterized solely as a cost and pricing issue. A discussion among industry leaders reaches a deeper, more complex conclusion.
FDA's First cGMP Enforcement Action On AI Misuse In Drug Manufacturing
The warning letter, issued to Purolea Cosmetics Lab, describes a manufacturer that used AI agents to generate drug product specifications and more. Here's why the outsourced pharma industry should take note.
Validating Candel's BLA-Ready Analytics Profile
The adenovirus/prodrug company discusses in-house assay development and the validation work to confirm CQAs like potency and cell line integrity.
Mapping Candel Therapeutics' Sprint To The BLA Finish Line
Leaders from the adenovirus/prodrug developer discuss the complex balancing act of preparing to scale up for commercial manufacturing without overextension.

PHARMA OUTSOURCING WHITE PAPERS

Accelerated API Manufacturing: Combining All Process Development Stages
During early-stage development, utilize the key considerations outlined in this paper to avoid common pitfalls and expedite the transition from molecule to market.

Importance Of Assessing Mannitol Crystallinity In Lyophilized Drug Products
Drug product stability may be seriously compromised if mannitol completes crystallization during storage rather than during the freezing or annealing step in the lyophilization process.
Stopper Migration In Frozen Pre-Filled Syringes
Review a semi-automated method for dynamically assessing plunger migration under controlled variations in temperature and pressure, utilizing computer vision tools.
FDA's Regenerative Medicine Advanced Therapy (RMAT) Program
RMAT qualification requires preliminary clinical evidence demonstrating the potential to address an unmet medical need. This designation grants benefits like intensive guidance and faster FDA review.
Optimizing DSP Development: Faster Timelines, Lower Costs, And High-Quality Processes
The biopharmaceutical industry faces growing downstream processing challenges in purifying complex biologics efficiently and at scale.
Safely Scaling High Potency API Manufacturing
Scaling HPAPI production demands disciplined containment and exposure control. Integrated operating models help manage risk while enabling compliant, reliable scale‑up.